Efficacy and Safety of inside stent for preoperative biliary drainage in patients with malignant hilar biliary obstruction: Prospective,multicenter,single-arm study.

Efficacy and Safety of inside stent for preoperative biliary drainage in patients with malignant hilar biliary obstruction: Prospective,multicenter,single-arm study. - Inside stent study for preoperative biliary drainage.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014111

Enrollment

Registered

2014-06-03

Start date

2014-08-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant hilar biliary obstruction.

Interventions

Inside-stent placement for preoperative biliary drainage in patients with malignant hilar biliary obstruction.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Malignant hilar obstruction of cancer of the biliary tract with indication for operation.

Exclusion criteria

Exclusion criteria: ECOG Performance Status is 4. ASA grade is 3-5. Hilar obstruction of HCC or metastatic tumor. Previous plastic stent placement across the sphincter of Oddi.

Design outcomes

Primary

Measure	Time frame
preoperative complication rate	—

Secondary

Measure	Time frame
postoperative complication rate. 3 month postoperative mortality. Technical success rate of endoscopic biliary stenting. Clinical success rate of preoperative biliary drainage. Patency of inside stent. Success rate of re-intervention.	—

Countries

Japan

Contacts

Public ContactYutaka Akimoto

Okayama University Hospital Department of gastroenterology and hepatology

qttsp974@gmail.com086-235-7219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026